Concept Mapping as a Scalable Method for Identifying Patient-Important Outcomes (VOICe)
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|ClinicalTrials.gov Identifier: NCT02792777|
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : April 24, 2018
|Condition or disease||Intervention/treatment|
|Concept Mapping Versus Interviews||Other: Interviews Other: Concept Mapping (CM)|
This is an observational study comparing two methods - concept mapping and one-on-one interviews. The investigators will test the methods themselves by comparing the comprehensiveness of the lists of patient-important outcomes obtained through each method (primary outcome) as well as the efficiency, as measured by resource intensiveness, of the methods (secondary outcome). The aims of this study will be tested with adult patients with moderately to poorly controlled diabetes mellitus who receive care at a large, urban, academic health system. In order to allow comparisons of the comprehensiveness of the methods in producing patient-important outcomes regardless of the healthcare setting in which outcomes are elicited, the investigators will recruit patients for the interview group from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The investigators will then recruit patient-participants from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. In Aim 2, the investigators will test the hypothesis that concept mapping in a research setting produces outcomes consistent with those elicited from patients in the "real-world" settings. In Aim 3, the investigators will assess the overall resource utilization, assessed primarily by time required from patients, the research team, and the advisory board, of qualitative interviews conducted to thematic saturation within a single healthcare setting compared to resources used for a single iteration of concept mapping.
Findings from this work will improve patient-centered outcomes research methods by providing researchers with information about standardized scalable methods to identify patient-important outcomes for use in research studies, so that individual patients are able to select outcomes that are most useful to them. In addition to providing insight regarding methods for eliciting patient-centered outcomes, the study will also provide valuable information to stakeholders regarding how patients' priorities vary across the care continuum. The investigators will report how findings from concept mapping apply across healthcare settings, and the degree to which patient priorities (based on interviews) differ across healthcare settings. If concept mapping results (collected in the research setting) capture the priorities identified by patients across different healthcare settings, this finding would enhance researchers' ability to perform studies in different, or multiple, settings. If the findings do not generalize across settings, this will be a valuable finding demonstrating that patient priorities differ across interview settings and patient acuity and will validate researchers' needs to be specific about the setting in which they choose to perform research to ensure they are reaching their intended patient population.
The work is being performed in close collaboration with the Patient and Key Stakeholder Advisory Board (PAKSAB) - equal partners with the research team who have been involved with the proposal from inception. PAKSAB members will be part of the research team throughout conducting the aims and assisting with all analysis and data interpretation.
|Study Type :||Observational|
|Actual Enrollment :||141 participants|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||January 29, 2018|
|Actual Study Completion Date :||March 2, 2018|
Interview participants will be recruited from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The total recruitment goal for this cohort is 90-120 participants.
Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo 10.0 software for coding and analysis.
Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. The total recruitment goal for this cohort is 60 people.
Other: Concept Mapping (CM)
The CM process consists of 3 steps that take place over 3 sessions:
Step 1: Generation of Ideas- Participants brainstorm and generate responses to the focus statement. Once the group agrees that no new statements are being generated, the list of statements is reviewed within the group.
Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance. Research staff enters this information into the CM software.
Concept Systems Global Software generates point maps using a technique that detects underlying similarities/differences between statements. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.
Step 3: Interpretation- The CM group revises the concept map. Participants review the cluster names suggested by the software and decide upon final naming of each cluster as a group.
- Comparison of methods in terms of comprehensiveness [ Time Frame: 01/2018-01/2019 ]
First, the investigators will determine the proportion of outcome themes identified in each interview settings that are present in 1) the list of outcome clusters generated from the initial concept mapping session and 2) an aggregate list of outcome clusters from all three concept mapping sessions. The investigators will also identify the presence of additional outcomes clusters in the concept mapping groups that were not identified in interviews.
Then the investigators will measure the comprehensiveness of outcomes as elicited in one concept mapping session compared to multiple sessions. The investigators will assess "concept mapping saturation," wherein we compare the cluster themes that emerge from each CM group. The investigators will use the outcomes from our first group as the "baseline data," and will determine the amount of new data added from including a second/third group. This assessment will allow us to draw a basic "concept mapping saturation curve."
- Comparison of methods in terms of efficiency [ Time Frame: 01/2018-01/2019 ]The investigators will assess the efficiency of implementation of the two methods, with efficiency including primarily measures of overall time of researchers, patient-partners, and patient-participants required for method completion. The investigators will compare the efficiency of conducting one concept mapping iteration to the efficiency of performing one set of interviews done to theme saturation. The efficiency of each method will be assessed by measuring overall resource utilization for conducting that method. Then, they will determine the resource intensiveness for completion of a single concept mapping iteration through to completion, and for one set of interviews performed to saturation. Collection of the data points will be performed during the design and implementation of Aim 1. This efficiency analysis is structured for what would need to be budgeted for in a grant application, and will provide useful information for general planning needs for method implementation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792777
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|